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FDA 510(k)

GLOVETEX (MULTIPLE)

K-Number: K952197 · 1995-08-14

ApplicantPt Mbf Buana Multicorpora
Decision Date1995-08-14
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

GLOVETEX (MULTIPLE) is the device name listed in this FDA 510(k) record. The listed applicant is Pt Mbf Buana Multicorpora. It received FDA 510(k) clearance on 1995-08-14 under 510(k) number K952197. The device is classified under product code LYY. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GLOVETEX (MULTIPLE)?

GLOVETEX (MULTIPLE) is a medical device that received FDA 510(k) clearance on 1995-08-14. The listed applicant is Pt Mbf Buana Multicorpora. The 510(k) number is K952197.

When did GLOVETEX (MULTIPLE) receive FDA 510(k) clearance?

GLOVETEX (MULTIPLE) received FDA 510(k) clearance on 1995-08-14, under 510(k) number K952197.

Who is the listed applicant for GLOVETEX (MULTIPLE)?

The FDA 510(k) record lists Pt Mbf Buana Multicorpora as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GLOVETEX (MULTIPLE)?

The FDA product code for GLOVETEX (MULTIPLE) is LYY.

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Other records listing Pt Mbf Buana Multicorpora as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K970115POWDER FREE LATEX EXAMINATION GLOVES

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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